This invention relates to medical apparatus including fluid conduits having a tamper-evident indicator and more particularly to such apparatus wherein the tamper-evident indicator is provided at the juncture of interconnected sections of the medical fluid conduits to provide an indication that the sections have or have not been disconnected and then reconnected.
Human body fluid drainage systems, such as urine collection systems, often include a catheter, such as a Foley catheter, having its distal end disposed in the bladder of a patient and the proximal end connected to a tube connector or adaptor of a drainage tube which connects the catheter with a urine collection container or bag.
Such Foley catheters are often maintained in position in a hospitalized patient and connected to the drainage bag for substantial periods of time. To avoid patient infections, such components are usually sold in a sterile condition. However, if the components are packaged and sold separately, there is a danger of bacteria entering the urine drainage system upon assembly and connection of the catheter to the drainage tube in the field, such as in a hospital and thereby causing urinary tract infection of a patient. To avoid the possibility of bacteria entering the system at the time of connection at the juncture of the catheter and drainage tube, some manufacturers preconnect the catheter and drainage tube at the factory, sterilize the preconnected system, and package and sell the system in the assembled condition.
Certain hospital requirements necessitate the disconnection and reconnection of the catheter and drainage tube of urine collection systems such as where a replacement bag is required or bladder irrigation is desired without the removal of the original catheter from the patient. Additionally, patients sometimes are motivated to disconnect the drainage bag and tube from the catheter without authorization for reasons of patient mobility, convenience, comfort and the like. It is, of course, important to hospital personnel to know if the system connectors have been tampered with or if disconnection and reconnection of the connectors has occurred, whether or not such was for an authorized purpose. For example, when monitoring or measuring urine drainage, it is necessary to know if there has been a disconnection of the urine collection container from the catheter in order to have confidence in the determination of total amount of urine passed.
In order to provide an assured indication that the catheter has or has not been disconnected and reconnected, a tamper-evident seal has been suggested. For example, U.S. Pat. No. 4,194,509 to Pickering et al proposes a tamper-evident shrink bank or wrap which seals the juncture of the catheter and drainage tube adaptor prior to sterilization. This heat shrinkable wrap of Pickering et al consists of a length of heat shrinkable adhesive tape and a circumferentially extending tear strip made of a shrinkable resin, for example, a polyolefin such as a polyethlene. In order to apply this wrap material, a heat source must be used to shrink the wrap and this tends to complicate the overall manufacture and assembly of the system. When the tamper-evident indicator or seal of Pickering et al is in position, it conceals the juncture of the adaptor and the funnel connector of the Pickering et al device thereby making it subsequently difficult to ascertain that a proper, fluid-tight engagement exists between these elements. In order to disconnect these elements for any purpose, the tear strip of Pickering et al must be located, gripped and tangantially pulled away from the adaptor to thus remove half of the wrap from the remainder thereof and thus making removal unnecessarily complicated. Additionally, after that portion of the wrap on the adaptor of the Pickering et al device is removed with the tear strip from the remainder of the wrap of the indicator remaining on the funnel connector, it is not always apparent from the smooth band of wrap remaining that the connection between the adaptor and the funnel connector has been previously broken.